Biotechnology

Company Overview of Stemedica Cell Technologies, Inc.

Company Overview

Stemedica Cell Technologies, Inc., a biopharmaceutical company, engages in the development and manufacture of adult stem cells and stem cell factors for research institutions and hospitals for pre-clinical and clinical studies. The company was incorporated in 2005 and is based in San Diego, California with a subsidiary location in Lausanne, Switzerland.

Stemedica Cell Technologies, Inc. Key Developments

Stemedica Cell Technologies, Inc. and Stemedica International S.A. Enroll into a New Study at Emory University in Atlanta and University of California

Jul 27 16

Stemedica Cell Technologies, Inc. and its subsidiary, Stemedica International S.A. have announced the opening of enrollment into a new study at Emory University in Atlanta and University of California, Irvine (UCI). The study is entitled, A Phase IIa Multicenter, Randomized, Single-blind, Placebo-controlled, Crossover Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer's Disease. The study will enroll approximately 40 subjects diagnosed with mild to moderate dementia due to Alzheimer's disease (AD) at least 3 months prior to enrollment, based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's disease and Related Disorders Association (NINCDS-ADRDA) Alzheimer's criteria.

Stemedica Cell Technologies, Inc. (Stemedica) received an FDA investigational new drug (IND) approval for a United States-based, Phase IIa clinical study using its ischemic tolerant, adult allogeneic mesenchymal stem-cells (itMSC) to treat subjects with traumatic brain injury (TBI). The study is sponsored by Stemedica with ProMedica Health Care Systems of Toledo, Ohio serving as both the trial site and a co-financial supporter of the trial. The clinical trial is titled ‘A Phase IIa, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Human Mesenchymal Stem Cells to Subjects with Moderate Traumatic Brain Injury.’ Stemedica's bone marrow-derived, allogeneic itMSCs are unique because they are grown under hypoxic conditions that more closely resemble the environment in which they live in the body. Compared to other MSCs, itMSCs secrete higher levels of growth factors usually associated with angiogenesis and healing. Stemedica's itMSCs are manufactured at its government licensed, cGMP (current good manufacturing practices) facility in San Diego, California. According to the Centers for Disease Control and Prevention (CDC), causes of TBI include falls, motor vehicle crashes, colliding with a person or object and assault. Symptoms of TBI include balance problems; double or blurry vision; sensitivity to light or noise; concentration or memory problems; and mood changes such as irritability, sadness, nervousness and anxiety. In 2010, 2.5 million emergency room visits, hospitalizations or deaths were related to TBI alone, total costs of which exceed $82 billion annually, including medical and work loss costs. The Phase IIa clinical trial will enroll approximately twenty-four (24) patients as part of its study population.

Stemedica Cell Technologies, Inc. announced completion of enrollment into 'A Phase I/IIa, Multi-Center, Open-Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Allogeneic Mesenchymal Bone Marrow Cells to Subjects with Ischemic Stroke'. This study focused on patients who were at least six months post-stroke with significant functional or neurologic impairment (defined as confined to a wheelchair or required to have home nursing care or assistance with the general activities of daily living). In addition, inclusion criteria specified that patients have no substantial improvement in neurologic or functional deficits for the two months prior to enrollment in the study. The primary goal of this study is to evaluate the safety and tolerability of Stemedica's ischemia-tolerant allogeneic mesenchymal bone marrow cells (itMBMC) administered intravenously. Patient status is assessed at specified time points over a period of 12 months using the following assessment scales: National Institutes of Health Stroke Scale (NIHSS), Mini Mental Status Exam (MMSE), Barthel Index (BI) and The Geriatric Depression Scale (GDS). This study was conducted at three clinical sites: the University of California, San Diego; Mercy Gilbert Medical Center, Arizona; and University of California, Irvine. Phase I of this trial was a dose-escalation study evaluating three doses of stem cells, with five subjects per dose receiving it MBMC based on weight: 0.5, 1.0 and 1.5 million mesenchymal cells per kilogram body weight. At the completion of the treatment of each dose cohort, a safety review was conducted by a Data Safety Monitoring Board (DSMB) prior to treatment at the next dose level. Fifteen patients were treated in Phase I of this study and the DSMB unanimously recommended continuing the study into Phase IIa. An additional 21 patients were treated at a dose of 1.5 million cells per kilogram body weight. Of the 36 patients treated in this study, 14 patients have already completed a 12 month follow-up. Only one mild adverse event was attributed to the investigational product. There were no serious adverse events or deaths in the study attributed to the product. No clinically-significant changes in laboratory or imaging results were reported. Although the cells are allogeneic (not the patient's own cells but from a healthy donor), the laboratory findings did not indicate an immune response and no immunosuppressive drugs were used in the clinical study. The majority of patients experienced improvement of their conditions in comparison to the baselines as assessed by the NIHSS, MSE, BI and GDS scales.

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